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Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy (SASER)

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ClinicalTrials.gov Identifier: NCT03200769
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy. The primary goal is to evaluate the efficacity after 3 months of obstructive sleep apnea syndrome treatment by CPAP on the epilepsy seizures frequency.

Condition or disease Intervention/treatment Phase
Sleep Apnea Syndromes Epilepsies, Partial Device: CPAP active Device: CPAP placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy
Study Start Date : July 2014
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
No Intervention: Group I
AHI/h < 15
Experimental: Group IIa
15 < AHI/h < 30. Randomization group. Intervention : CPAP active
Device: CPAP active
CPAP PR1 Philips Respironics with a pression between 4 and 14 mm Hg

Experimental: Group IIb
15 < AHI/h < 30. Randomization group. Intervention : CPAP placebo during the first 3 months. After this period, the patient will have the possibility to continue with an active CPAP.
Device: CPAP placebo
CPAP PR1 Philips Respironics with a constant pression of 4 mm Hg.

Active Comparator: Group III
AHI/h > 30. Intervention : CPAP active
Device: CPAP active
CPAP PR1 Philips Respironics with a pression between 4 and 14 mm Hg




Primary Outcome Measures :
  1. Number of patients from group IIa and IIb with decreased seizure frequency [ Time Frame: At 3 months ]
    Decreased > 50% after CPAP treatment


Secondary Outcome Measures :
  1. Number of patients from group IIa and IIb with decreased seizure frequency [ Time Frame: At 6 months ; At 12 months ]
    Decreased > 50% after CPAP treatment

  2. Number of patients from group III with decreased seizure frequency [ Time Frame: At 3 months ; At 6 months ; At 12 months ]
    Decreased > 50% after CPAP treatment

  3. Impact of AHI on the number of night seizures [ Time Frame: At 12 months ]
    Does the AHI has an impact on the number of night seizure?

  4. Impact of the localisation and the type of epilepsy based on patient medical history exam (video-electroencephalogram) on the SAS risk [ Time Frame: At 12 months ]
    Does the AHI is impacted by the localisation and the type of epilepsy?

  5. Number of seizures based on the seizures diary [ Time Frame: At 12 months ]
    Impact of SAS treatment on the pharmacoresistance

  6. Number of patients who became drug-susceptible based on the seizures diary [ Time Frame: At 3 months ; At 6 months ; At 12 months ]
    Impact of SAS treatment on the pharmacoresistance

  7. Quality of life questionnaire (QOLIE 31) [ Time Frame: At 3 months ; At 6 months ; At 12 months ]
    Impact of SAS treatment on the quality of life

  8. Anxiety and depression questionnaire (BECK) [ Time Frame: At 3 months ; At 6 months ; At 12 months ]
    Impact of SAS treatment on anxiety and depression

  9. Somnolence questionnaire (Epworth) [ Time Frame: At 3 months ; At 6 months ; At 12 months ]
    Impact of SAS treatment on somnolence

  10. Cognitive capacity questionnaire (MOCA) [ Time Frame: At 3 months ; At 6 months ; At 12 months ]
    Impact of SAS treatment on cognitive capacity questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female age ≥ 18.
  • Patient suffering of pharmacoresistant epilepsy.
  • Frequency of epilepsy crisis : minimum 4 per month.
  • Antiepileptic drug on a stable dose for at least 2 months.
  • SA-SDQ score ≥ 25.
  • Written informed consent obtained.
  • Patient affiliated with a social security regimen.

Exclusion Criteria:

  • Pregnant females (female subjects who are lactating are not excluded).
  • Anterior CPAP treatment.
  • Central apnea >20% during the initial polysomnography.
  • Mental retardation or severe cognitive impairment.
  • Presence of pseudo-crisis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200769


Contacts
Contact: Philippe DERAMBURE, MD, PhD philippe.derambure@chru-lille.fr
Contact: Flavien Gautron, Study Co flavien.gautron@chru-lille.fr

Locations
France
CHRU de Lille - Rue Emile LAINE - Hopitâl Roger Salengro Rez de Chaussée - Neurophysiologie Clinique Recruiting
Lille, France, 59037
Contact: Philippe Derambure, MD PHU       philippe.derambure@chru-lille.fr   
Contact: Flavien Gautron, Study Co       flavien.gautron@chru-lille.fr   
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Philippe DERAMBURE, MD, PhD University Hospital, Lille

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03200769     History of Changes
Other Study ID Numbers: 2012_66
2013-A01156-39 ( Other Identifier: ID-RCB number, ANSM )
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Keywords provided by University Hospital, Lille:
CPAP
Sleep Apnea Syndrome
Pharmacoresistant Epilepsy
Apnea Hypopnea-Index

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Syndrome
Apnea
Epilepsy
Epilepsies, Partial
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Brain Diseases
Central Nervous System Diseases